European

Commission

Factsheet for Manufacturers

of Implantable Medical Devices

This factsheet is aimed at manufacturers of implantable

medical devices and relates to the application of Article What You Need to Know
18 of Regulation (EU) 2017/745 of the European Parlia-
ment and the Council of 5 April 2017 on medical devices.
About Implant Cards
For further information and specific examples of implant
card designs, consult the guidance document MDCG Fig 1: Sam
2019 8 V2. ple Implan
t Card

85.6 mm

Background: Internatio
nal Implan
t Card
John Smit
The new Regulation (EU) 2017/745 on medical devices h
(MDR) puts in place a reinforced legal system for 27/05/20
54 mm 21
medical devices that prioritises transparency and ABC Healt
hcare Cen
patient access to information. With these goals in ter
123 Medic
al Parkwa
mind, the Regulation introduces a new requirement for Dr. H.C. P
y, Cork, I
reland PM-550
implantable medical device manufacturers to provide rofession
al
UDI-DI: (0
an ‘implant card’ (IC), offering patients easy access https://ww 1)01865
w.generic
m ed.com/p SN798562
to all relevant information concerning the device with atient implantinfo 1
Genericme
which they have been implanted. 500 Gene
d
ricmed P
www.generi
Front – No cmed.c
(handwritt t to scale
en text on
pre-printed
content)
B
(blank – se
rial
Handwritten
Purpose of an Implant Card text
Content prin
ted on manuf
a

Implant cards serve various purposes. They:

Enable patients to identify

themselves as persons requiring
Enable the patient to identify the
special care in certain situations,
implanted device and to get access
such as during security checks, and
to safety-related information (e.g.
inform emergency clinical staff or first
via the EUDAMED database website).
responders about the special care/needs
of specific patients.

1
Health
 Medical Devices Requiring
an Implant Card

ALL manufacturers of implantable medical devices should 4

Serial number or, where applicable, lot or batch number;
provide the required information on an implant card to be delivered
with the device.
5
Name and address of the manufacturer of the medical device;
The following implants are exempt from the implant card
obligations: sutures, staples, dental fillings, dental braces, tooth 6
Website of the manufacturer of the medical device.
crowns, screws, wedges, plates, wires, pins, clips and connectors.
In addition, the manufacturer should design the IC in such a way
that it includes the following blank fields to be filled out by the
implanting healthcare institution or healthcare provider:
Requirements for Manufacturers:
Name of the patient or patient ID;
1
Under Article 18 paragraph 1a of the MDR, manufacturers should
provide the following necessary information on the IC (preferably
Date of implantation.
2
on the card itself or, alternatively, as stickers to be placed by the
clinician).
Name and address of the healthcare institution that
3
performed the implantation;
1
Device name;

2
Device type;
Size Requirements:
3
Unique device identification (UDI) – the UDI should be in
automatic identification and data capture (AIDC) format, The outer dimensions of the IC should be the same as those of
e.g. linear or 2D-barcodes, and the UDI device identifier a credit card, ATM card or ID card (85.6 mm × 53.98 mm) with a
(UDI-DI) should be in human-readable format; radius of 2.88–3.48 mm.

Fig 1: Sample Implant Card

85.6 mm

International Implant Card

1
1
John Smith
2 27/05/2021
54 mm
ABC Healthcare Center PM-5503 Pacer Advanced 2
3
123 Medical Parkway, Cork, Ireland 3
UDI-DI: (01)01865494261654
Dr. H.C. Professional
SN79856214 4
Genericmed
https://www.genericmed.com/patientimplantinfo 500 Genericmed Place, Minneapolis, MN 55123 USA
www.genericmed.com
5

6
Front – Not to scale Back – Not to scale
(handwritten text on pre-printed content) (blank – serial printed content in production)

Handwritten text Content printed on manufacturing line Pre-printed text (from supplier)

See MDCG 2019-8 V2, Annex 1 for additional IC examples and information.

2

Ease of Reading Requirements:
The text provided on the IC, and on the instructions for completing
the IC by the healthcare institution or healthcare provider, must be
legible and at least 2 millimetres high. ‘Text’ includes any number,
letter or symbol, including letters and numbers in a symbol.
The information shall be written in such a way that it can be
readily understood by a layperson, and provided by any means
that allow rapid access to the information, in the language(s)
determined by the relevant Member State.
Use of Symbols
To avoid national versions of the IC, the use of symbols is advisable.
An explanation of the symbols on the IC should be provided in
a leaflet or on the back of the IC, if space allows. For a list of
symbols recommended for use on the IC, consult MDCG 2019-8 V2.
Use of Language in
a Member State
The information provided on the IC should be written in the
language(s) required by the relevant Member State.
Despite the nearly complete list of symbols for fields on the IC,
there is currently no symbol available for the required field “Device
Type”. The lack of a symbol and the purpose of this field make
it necessary to provide the information on the device type in the
language accepted/required by the relevant Member State.
There are several possibilities available to provide this information
in the necessary languages, e.g., the information is already printed
on the IC in the different languages, or stickers are provided with
the IC and the healthcare professional selects the correct one,
for example.
Use of an Implant
Card Leaflet
Device manufacturers should provide, together with the IC,
instructions for the healthcare professional on how to complete
the IC and to explain the symbols used. This information should
be provided in the language(s) required by the relevant Member
State. For this reason, a leaflet containing the relevant information,
to be provided together with the IC and the implantable device,
is the recommended solution.
In addition to the information on the IC itself, the following infor-
mation must also be provided together with the IC and the device
(Article 18 paragraph 1 b-d). One solution is to also include this
information in the IC Leaflet:
1. Any warnings, precautions or measures to be taken by the
patient or a healthcare professional with regard to reciprocal
interference with reasonably foreseeable external influences,
medical examinations or environmental conditions;
2. Any information about the expected lifetime of the device
and any necessary follow-up;
3. Any other information to ensure safe use of the device by
the patient, including qualitative and quantitative information
on the materials and substances to which patients can be
exposed.
Updates to the IC Information:
IC information should be updated where and when appropriate.
Updates of the information should be made available to the
patient via a website, which should be indicated on the IC.
Implantable Systems
If an implantable device contains implantable components that
might be replaced by other (or the same) components, for example
in case of a later revision, the manufacturers should consider
the use of a System IC. Consult MDCG 2019-8 V2, Annex I for an
example.
3
 Frequently Asked Questions

1. Do ICs need to be provided retrospectively for
devices already placed on the market under Directive
90/385/EEC?
No. Article 18 requirements apply only to devices placed on the
market under Regulation (EU) 2017/745.
5. Do the requirements for implant cards apply to
resorbable implants?
The MDR definition of “Implant” includes resorbable devices.
All implants that are not on the exemption list must have an
implant card.

2. Are manufacturers of implantable medical devices
required to have a website through which they can
communicate with patients receiving an implant?
Yes. The manufacturer’s website is to be included on the IC, in
accordance with Article 18 paragraph 1(a).
3. Can a QR code be used to identify the manufacturer’s
website rather than a URL?
It is not expected that patients would be able to easily access the
information via a QR code; therefore, the website URL should be
identified on the IC. The patient must be able to readily understand
the information and get rapid access to the information on the
website.
6. Can the UDI on the IC be machine readable?
The UDI is a series of numeric or alphanumeric characters that
is created through a globally accepted device identification and
coding standard. It allows the unambiguous identification of a
specific device on the market. The UDI is comprised of the device
identifier (UDI-DI) and the production identifier (UDI-PI). The UDI
is to be included on the IC in automatic identification and data
capture (AIDC) format, e.g. linear or 2D-Barcodes, and the IC must
include the UDI-DI in human-readable format.
7. Does the IC need to include both UDI-DI and UDI-PI?
Yes. Both the UDI-DI and UDI-PI must be on the implant card.

4. Are there any GDPR privacy concerns regarding the

identity of the patient?

According to Article 18 paragraph 2, only the physical implant

card provided to the patient by the healthcare institution/provider
should bear the identity of the patient. The patient’s name will
be completed at the point of care and the implant card is then
given to the patient.

01/27/2021

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